MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Novum IQ; Pump, infusion

Model Number	40700BAXUS
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a novum iq large volume pump infused at a different rate than programed.This was observed in the biomedical service department.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.The event history log was reviewed; however, the date of the reported event could not be identified.Infusions were investigated and no excessive alarms or programming errors were identified.Functional flow rate accuracy testing was performed and the device met specifications.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: Novum IQ
• Common Device Name: Pump, infusion
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ORBRAY THAILAND CO., LTD.; northern region ind. estate; 60/29 moo 4, tambol banklang; a.muang, ban klang, lamphun NA 51000 ; TH 51000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50214569
• Report Number: 1416980-2026-02613
• Device Sequence Number: 14977214
• Product Code: FRN
• UDI-Device Identifier: 05413765851797
• UDI-Public: (01)05413765851797
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K211122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40700BAXUS
• Device Catalogue Number: 40700BAXUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown